Vitamin D and Mortality in Heart Failure (EVITA)

This study is currently recruiting participants.
Verified December 2013 by Heart and Diabetes Center North-Rhine Westfalia
Sponsor:
Information provided by (Responsible Party):
Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier:
NCT01326650
First received: March 29, 2011
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

Despite significant therapeutic improvements, congestive heart failure (CHF) patients still have a poor prognosis. Currently, 5-year survival rates are only 35-50%. There is an accumulating body of evidence from prospective cohort studies that low circulating 25-hydroxyvitamin D is an independent predictor of all-cause and cardiovascular mortality, respectively. Vitamin D deficiency is prevalent among CHF patients. We hypothesize that vitamin D may improve survival in CHF patients. We therefore aimed to investigate whether vitamin D supplementation reduces mortality and increases event-free survival in end-stage CHF patients.


Condition Intervention Phase
Congestive Heart Failure
Drug: Vitamin D
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Vitamin D on All-cause Mortality in Heart Failure Patients

Resource links provided by NLM:


Further study details as provided by Heart and Diabetes Center North-Rhine Westfalia:

Primary Outcome Measures:
  • Number of participants who died during the intervention [ Time Frame: three years ] [ Designated as safety issue: No ]
    all-cause mortality (any cause of death) will be assessed


Secondary Outcome Measures:
  • Number of event-free survivors [ Time Frame: three years ] [ Designated as safety issue: No ]
    event defined as: death from any course, cardiac transplantation, high urgent listing for cardiac transplantation, rescucitation, hospitalisation, ventricular assist device implantation

  • Changes in biochemical risk markers [ Time Frame: three years ] [ Designated as safety issue: No ]
    inflammation markers, kidney parameters, lipid parameters, haemostasis parameters

  • Number of participants with elevated safety parameters [ Time Frame: every 6 months ] [ Designated as safety issue: Yes ]

    Serum 25-Hydroxyvitamin D should not exceed 150 ng/ml.

    Serum calcium should not exceed 2.75 mmol/l.



Estimated Enrollment: 1000
Study Start Date: November 2010
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D
daily vitamin D supplement
Drug: Vitamin D
daily oral vitamin D supplement of 100 mikrograms for three years
Placebo Comparator: placebo Drug: placebo
daily oral placebo supplement for three years

  Eligibility

Ages Eligible for Study:   18 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • > 18 years of age and < 80 years of age
  • New York Heart Association Functional Class > = II

Exclusion Criteria:

  • preganncyand lactation
  • sarcoidosis
  • chronic kidney disease (stage 4 and 5)
  • daily vitamin D intake > 20 mikrograms
  • serum 25-hydroxyvitamin D > 30 ng/ml
  • hypercalcemia
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01326650

Locations
Germany
Heart Center North Rhine-Westphalia Recruiting
Bad Oeynhausen, Federal State of North Rhine-Westphalia, Germany, 32545
Contact: Armin Zittermann, PhD    +49 5731 97 ext 1912    azittermann@hdz-nrw.de   
Contact: Jana B Ernst, MSC    +49 5731 97 ext 3411    bernst@hdz-nrw.de   
Sub-Investigator: Armin Zittermann, PhD         
Sponsors and Collaborators
Heart and Diabetes Center North-Rhine Westfalia
Investigators
Study Chair: Armin Zittermann, PhD Heart Center North Rhine-Westphalia
Principal Investigator: Jochen Börgermann, MD Heart Center North Rhine-Westphalia
  More Information

Publications:

Responsible Party: Heart and Diabetes Center North-Rhine Westfalia
ClinicalTrials.gov Identifier: NCT01326650     History of Changes
Other Study ID Numbers: 004
Study First Received: March 29, 2011
Last Updated: December 10, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Heart and Diabetes Center North-Rhine Westfalia:
vitamin D, mortality, event-free survival, heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on April 16, 2014